MAUDE Adverse Event Report: LUMENIS LTD SLIMLINE SIS EZ; POWERED LASER SURGICAL INSTRUMENT

Model Number	0644-019-01
Medical Device Problem Codes	Defective Device (2588); Device Contaminated During Manufacture or Shipping (2969); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during preparation for retrograde intrarenal surgery (rirs) procedure, while unpacking fiber, a foreign body dropped out from packing.The device was removed.The fiber was replaced, and the procedure was completed using another of same model with no patient complications.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this fiber was thoroughly analyzed.Microscope inspection identified that the tip was in good condition, however, there were burn marks on the connector and light was passing through the connector.Also, the aiming beam was bright and round.However, visual inspection identified that the radio-frequency identification (rfid) chip was separated from the connector, the rfid chip is part of the fiber.This component is placed into the connector with gluing and most likely with handling or sterilization after usage the connector rfid chip became loose and fell out.Therefore, the reported event was confirmed.
Event or Problem Description
It was reported that, during preparation for retrograde intrarenal surgery (rirs) procedure, while unpacking fiber, a foreign body dropped out from packing.The device was removed.The fiber was replaced, and the procedure was completed using another of same model with no patient complications.
Event or Problem Description
It was reported that, during preparation for retrograde intrarenal surgery (rirs) procedure, while unpacking fiber, a foreign body dropped out from packing.The device was removed.The fiber was replaced, and the procedure was completed using another of same model with no patient complications.It was confirmed that the foreign matter that dropped out was part of the fiber.
Additional Manufacturer Narrative
This report is report is being submitted to correct the device codes (h6) field in section h, device manufacturers only.This report is report is being submitted to correct the additional mfr narrative (h11) field in section h, device manufacturers only.Upon receipt at our post market quality assurance laboratory, this fiber was thoroughly analyzed.Microscope inspection identified that the tip was in good condition.However, there were burn marks on the connector face and light was passing through the connector.Functional test identified that the aiming beam was bright and round.However, visual inspection identified that the radio-frequency identification (rfid) chip was separated from the connector, this component is placed into the connector with gluing and possibly with handling or sterilization after usage the connector fragment became loose and fell out.Therefore, the reported event was confirmed.The manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the alleged event of foreign matter dropping out of the packaging, as the foreign body was the rfid chip which is a component of the fiber.

• Brand Name: SLIMLINE SIS EZ
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): MOLEX LLC; 18019 n 25th ave; phoenix AZ 85023
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21775916
• Report Number: 2124215-2025-20222
• Device Sequence Number: 9821413
• Product Code: GEX
• UDI-Device Identifier: 07290109145587
• UDI-Public: (01)07290109145587(17)270823(10)4010922
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0644-019-01
• Device Catalogue Number: 0644-019-01
• Device Lot Number: 0004010922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 07/29/2025; 09/26/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 08/21/2025; 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown